MHRA-100081-PIP01-21

Key Facts

Active Substance
  • Zibotentan
  • DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE
Invented Name
Not available at present
PIP Number MHRA-100081-PIP01-21
Pharmaceutical form(s)
  • Tablet
  • hard capsule
Therapeutic area
Therapeutic area:
  • Other: Renal Disease
Conditions / Indications
Conditions / Indications:
  • Treatment of Chronic Kidney Disease
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(s).
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Zibotentan;DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE.pdf
Published Date 17/12/2021